Olympus A22201BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761021319), received between Aug 14, 2020 and Aug 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE DETACHED AND FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10447562 ↗
• MalfunctionAug 14, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE AT AN UNKNOWN DATE, A SPARK OCCURRED THAT CAUSED THE ENTIRE SCREEN TO TURN WHITE AND THEN THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE AND WIRE FRAGMENTS POSSIBLY MAY HAVE FALLEN INTO THE PATIENT. HOWEVER, AN X-RAY EXAMINATION WAS PERFORMED BUT NO FRAGMENTS COULD BE LOCATED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10405989 ↗